The vagina is a dynamic ecosystem that normally contains approximately 109 bacterial colony-forming units per gram of vaginal fluid. The normal vaginal fluid is clear to white, odorless, and of high viscosity. Normal bacterial flora is dominated by lactobacilli, however, a variety of other organisms, including some potential pathogens, are also present at lower concentrations.
Normally, the action of Lactobacilli converts glycogen to lactic acid, whereby the lactic acid provides a physiologic lowering of pH. The normal vagina of a woman of reproductive age has a pH of 3.8 to 4.2. This lower pH provides a protection by making the vaginal environment less hospitable to certain pathogens, specifically certain yeast and other bacteria.
Some lactobacilli also produce hydrogen peroxide (H2O2), which has microbicidal properties that can kill bacteria and viruses.
When the normal balance of microorganisms is disrupted, bacterial vaginosis can occur, leading to vaginal discomfort ranging from itching to a burning sensation along with vaginal discharge. Vaginal discharge is one of the most common conditions for which women seek medical care. Approximately 10 million office visits each year are attributed to vaginal discharge complaints.
The present inventors have discovered that a two-part chemical system, preferably formed from acetic acid and hydrogen peroxide, can aid in achieving stasis of the vaginal flora, returning the vaginal canal to its normal pH and mitigating the effects of bacterial vaginosis.
One problem with this treatment is that the chemicals must be admixed just prior to their application to the vaginal canal in order to maintain maximum effectiveness. Although it would be ideal to instill such a solution as desired, having to carry around the individual components of the chemical system in separate portions, mixing them and then inserting the blended components into the vaginal canal is cumbersome and inconvenient. Therefore, such treatments have generally been instilled in the home or at a doctor's office.
If a portable device could be provided which enabled easy transport of such a chemical system, and further provided for ease of intermixing and subsequent insertion into the vaginal canal, a long felt need would be realized.